Reduction of Major Amputations after Surgery Versus Endovascular Intervention: The BEST-CLI Randomised Trial.

OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.

Tranexamic acid is not associated with a higher rate of thrombotic-related reintervention after major vascular injury repair.

BACKGROUND: Tranexamic acid (TXA) is associated with lower mortality and transfusion requirements in trauma patients, but its role in thrombotic complications associated with vascular repairs remains unclear. We investigated whether TXA increases the risk of thrombosis-related technical failure (TRTF) in major vascular injuries (MVI). METHODS: The PROspective Observational Vascular Injury Treatment (PROOVIT) registry was queried from 2013 to 2022 for MVI repaired with an open or endovascular intervention. The relationship between TXA administration and TRTF was examined. RESULTS: The TXA group (n = 297) had higher rates of hypotension at admission (33.6% vs. 11.5%, p < 0.001), need for continuous vasopressors (41.4% vs. 18.4%, p < 0.001), and packed red blood cell transfusion (3.2 vs. 2.0 units, p < 0.001) during the first 24 hours compared with the non-TXA group (n = 1941), although demographics, injury pattern, and interventions were similar. Cryoprecipitate (9.1% vs. 2%, p < 0.001), and anticoagulant administration during the intervention (32.7% vs. 43.8%, p < 0.001) were higher in the TXA group; there was no difference in the rate of factor VII use between groups (1% vs. 0.7%, p = 0.485). Thrombosis-related technical failure was not different between the groups (6.3% vs. 3.8 p = 0.141) while the rate of immediate need for reoperation (10.1% vs. 5.7%, p = 0.006) and overall reoperation (11.4% vs. 7%, p = 0.009) was significantly higher in the TXA group on univariate analysis. There was no significant association between TXA and a higher rate of immediate need for reintervention (odds ratio [OR], 1.19; 95% confidence interval [CI], 0.75-1.88; p = 0.465), overall reoperation rate (OR, 1.33; 95% CI, 0.82-2.17; p = 0.249) and thrombotic events in a repaired vessel (OR, 1.07; 95% CI, 0.60-1.92; p = 0.806) after adjusting for type of injury, vasopressor infusions, blood product and anticoagulant administration, and hemodynamics. CONCLUSION: Tranexamic acid is not associated with a higher risk of thrombosis-related technical failure in traumatic injuries requiring major vascular repairs. Further prospective studies to examine dose-dependent or time-dependent associations between TXA and thrombotic events in MVIs are needed. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

The Order of Operative Repair Does Not Influence Outcomes in Patients with Concomitant Popliteal Artery and Orthopedic Injuries.

BACKGROUND: The most challenging lower extremity traumatic injuries involve concomitant vascular and orthopedic injuries with amputation rates approaching 50%. Controversy exists as to how to prioritize the vascular and orthopedic repairs. We reviewed patients with popliteal artery and lower extremity orthopedic injuries to analyze the sequence of the vascular and orthopedic repairs on outcomes. METHODS: All adult patients with a diagnosis of concomitant popliteal artery and lower extremity fracture or dislocation were identified through a review of an institutional trauma registry performed at a level 1 trauma center from 2014 to 2019. Patient demographics, timing of presentation, injury severity score (ISS), surgical interventions, and limb outcome data were collected and examined. The sequence of operative repairs and factors influencing the operative order were analyzed. RESULTS: Twenty-nine patients were treated for popliteal artery injuries. Twelve of these 29 patients had concomitant popliteal artery and orthopedic fractures requiring surgical repair. Injury mechanisms included both blunt (50%, 6/12) and penetrating trauma (50%, 6/12); the majority involved femur fractures (58%, 7/12). Vascular repair included arterial bypass (75%, 9/12) or interposition grafts (25%, 3/12). Orthopedic repair included external fixation (83%, 10/12) and open reduction internal fixation (17%, 2/12). Vascular repair was performed first in 7/12 limbs (58%). Patients having vascular repair first had a trend toward lower blood pressure on arrival (P = 0.068). There was no significant difference in emergency department to operating room (OR) time, OR time, ISS, mangled extremity severity score, estimated blood loss, or blood transfusion for the sequence of operative repair. Fasciotomy was nearly ubiquitous, present in 11/12 patients (92%). There were no graft complications related to orthopedic manipulation, and there were no reported limb-length to graft-length discrepancies. Early limb salvage trended lower in the cohort with revascularization first (71% vs. 100%, P = 0.19). Of the remaining limbs available for follow-up, limb salvage at 4.25 years is 100%. CONCLUSIONS: In this small study of patients with concomitant lower extremity popliteal artery and orthopedic injuries, the order of operative repair does not appear to influence the success of revascularization.

Development of a convolutional neural network to detect abdominal aortic aneurysms.

Objective: We sought to train a foundational convolutional neural network (CNN) for screening computed tomography (CT) angiography (CTA) scans for the presence of infrarenal abdominal aortic aneurysms (AAAs) for future predictive modeling and other artificial intelligence applications. Methods: From January 2015 to January 2020, a HIPAA (Health Insurance and Accountability Act)-compliant, institutional review board-approved, retrospective clinical study analyzed contrast-enhanced abdominopelvic CTA scans from 200 patients with infrarenal AAAs and 200 propensity-matched control patients with non-aneurysmal infrarenal abdominal aortas. A CNN was trained to binary classification on the input. For model improvement and testing, transfer learning using the ImageNet database was applied to the VGG-16 base model. The image dataset was randomized to sets of 60%, 10%, and 30% for model training, validation, and testing, respectively. A stochastic gradient descent was used for optimization. The models were assessed by testing validation accuracy and the area under the receiver operating characteristic curve. Results: Preliminary data demonstrated a nonrandom pattern of accuracy and detectability. Iterations (≤10) of the model characteristics generated a final custom CNN model reporting an accuracy of 99.1% and area under the receiver operating characteristic curve of 0.99. Misjudgments were analyzed through review of the heat maps generated via gradient weighted class activation mapping overlaid on the original CT images. The greatest misjudgments were seen in small aneurysms (<3.3 cm) with mural thrombus. Conclusions: Preliminary data from a CNN model have shown that the model can accurately screen and identify CTA findings of infrarenal AAAs. This model serves as a proof-of-concept to proceed with potential future directions to include expansion to predictive modeling and other artificial intelligence-based applications.

Trends in Preoperative Imaging Prior to Elective Carotid Endarterectomy in the Southern California Vascular Outcomes Improvement Collaborative.

BACKGROUND: Duplex ultrasound (DUS) has been an important imaging modality for carotid bifurcation disease due to its low cost and noninvasive nature. Over the past decade, computed tomography angiography (CTA) has replaced conventional angiography (CA) due to safety and availability. There are significant differences in cost and patient exposures between CTA and DUS. The objective of this study is to analyze the trends in preoperative imaging modalities in the Southern California region for elective carotid endarterectomies (CEA). METHODS: A retrospective review of the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) was performed. All elective CEA procedures were identified from January 2011 through May 2020. Data included all preoperative imaging modalities used. An analysis was performed of the types and numbers of studies obtained. The trends in the usage of single and multiple preoperative studies and the trends in use of DUS versus CTA were analyzed. RESULTS: From January 2011 to May 2020, 2,519 elective CEAs were entered into the regional database. Of the 2,336 eligible cases (183 excluded due to incomplete data), 38% were for symptomatic (Sx) and 62% for asymptomatic (ASx) carotid disease. Preoperative imaging studies ordered included 56% DUS, 28% CTA, 6% magnetic resonance angiography, and 10% CA. Single imaging studies were used in 56.3% of cases, 2 studies in 40.4%, and >2 studies in 3.3%. A majority of both Sx and ASx patients undergoing elective CEA had only a single preoperative imaging study. ASx patients were more likely to have a single study than Sx patients (P = 0.0054). DUS was the most frequent single study ordered in both Sx and ASx patients, 37.4% and 41.4%, respectively. The trend over time shows a decreasing use of DUS and an increasing use of CTA for both Sx and ASx patients. In 2020, CTA overtook duplex as the most frequently ordered study for Sx patients. The average number of imaging studies per procedure per year for both Sx and ASx patients has not changed substantially at approximately 1.5 studies. In addition, the overall trend shows that although a single preoperative study was more common than 2 or more studies for elective CEA, single studies were more common for ASx patients, whereas the use of 2 or more studies was more common for Sx patients. The overall trend among three different time periods, 2011-2013, 2014-2016, and 2017-2020 shows that for both Sx and ASx patients, the use of single DUS studies has decreased over time (P < 0.001), whereas the use of single CTA studies has increased over time (P < 0.001). The use of CTA varied widely by a study center ranging from 12-53% for Sx and 10.5-75% for ASx patients. CONCLUSIONS: Over the past decade, most patients undergoing elective CEA in the SoCal VOICe had only a single preoperative imaging study with DUS as the most frequent sole study in both Sx and ASx patients. However, as a single study, CTA is becoming more frequently used than DUS. Further investigation into the variation in practice may help standardize imaging prior to CEA and control healthcare costs.

Pediatric Renal Artery Stenosis: A 19-Year Experience in Management and Outcomes at a Tertiary Pediatric Hospital.

BACKGROUND: Renal artery stenosis (RAS) is an uncommon cause of pediatric hypertension. Guidelines for workup and management have not been established. The most widely reported etiology of the pediatric renovascular disease has been fibromuscular dysplasia; however, other etiologies including middle aortic syndrome (MAS) and vasculitides have been described. We reviewed cases of radiologically identified pediatric RAS and describe etiologies, management, and long-term clinical outcomes in our patients. METHODS: Reports for duplex ultrasound, computed tomography angiography, magnetic resonance imaging, and conventional angiography from an academic children's hospital between 2000 and 2019 were evaluated. Positive reports for RAS were confirmed by a vascular surgeon and a radiologist. Demographics, indications for evaluation, management, and long-term clinical outcomes were documented. Data are summarized as count (n), geometric mean, median, or standard deviation as appropriate. Univariate differences between treatment cohorts were analyzed using Chi-squared tests for categorical variables. Nonparametric paired Wilcoxon signed-rank test and Mann-Whitney U-test were used for the analysis of paired ordinal or continuous data. A statistical analysis was performed with SPSS software (SPSS Inc., Chicago, IL) with significance defined at a P < 0.05 level. RESULTS: Imaging for suspected RAS was performed on 984 children. Of the 38 patients with positive imaging for RAS, 60.5% were idiopathic, 31.5% (n = 12) had concomitant congenital/systemic comorbidity, and 21.0% (n = 8) had RAS and concomitant aortic pathology. Fibromuscular dysplasia only accounted for 13.2% (n = 5) of patients. Regarding management, 34.2% (n = 13) underwent invasive intervention, 23.7% (n = 9) underwent endovascular intervention alone, and 10.5% (n = 4) underwent endovascular plus surgical intervention. Conservative management was performed for 65.8% (n = 25) of patients at a long-term follow-up (33.8 months), 34.2% (n = 13) requiring only lifestyle changes, and 31.6% (n = 12) requiring only medical management. CONCLUSIONS: Pediatric RAS is a low-frequency disease and long-term outcomes have been under-reported. The incidence of associated aortic pathology in our intervention cohort appears higher than that was previously reported. A long-term follow-up demonstrated that up to 65.8% of patients could be managed successfully with conservative therapy.

Analysis of Traumatic Axillo-Subclavian Vessel Injuries: Endovascular Management is a Viable Option to Open Surgical Reconstruction.

BACKGROUND: In traumatic axillo-subclavian vessel injuries, endovascular repair has been increasingly described, despite ongoing questions regarding infection risk and long-term durability. We sought to compare the clinical and safety outcomes between endovascular and surgical treatment of traumatic axillo-subclavian vessel injuries. METHOD: A search query of the prospectively maintained PROOVIT registry for patients older than 18 years of age with a diagnosis of axillary or subclavian vessel injury between 2014-2019 was performed at a Level 1 Trauma Center. Patient demographics, severity of injury, Mangled Extremity Severity Score (MESS), Injury Severity Score (ISS), procedural interventions, complications, and patency outcomes were collected and analyzed. RESULTS: Twenty-three patients with traumatic axillo-subclavian vessel injuries were included. There were similar rates of penetrating and blunt injuries (48% vs. 52%, respectively). Eighteen patients (78%) underwent intervention: 11 underwent endovascular stenting or diagnostic angiography; 7 underwent open surgical repair. There was similar severity of arterial injuries between the endovascular and open surgical groups: transection (30% vs. 40%, respectively), occlusion (30% vs. 40%, respectively). The open surgical group had worse initial clinical comorbidities: higher ISS scores (17.0 vs 13.5, p = 0.034), higher median MESS scores (6 vs. 3.5, P = 0.001). The technical success for the endovascular group was 100%. The endovascular group had a lower estimated procedural blood loss (27.5 mL vs. 624 mL, P = 0.03). The endovascular arterial group trended toward a shorter length of hospital stay (5.6 days vs. 27.6 days, P = 0.09) and slightly reduced procedural time (191.0 min vs. 223.5 min, P = 0.165). Regarding imaging follow up (average of 60 days post-discharge), 7 patients (54%) underwent surveillance imaging (5 with duplex ultrasound, 2 with computed tomography angiography CTA) that demonstrated 100% patency. Regardless of ISS or MESS scores, at long term clinical follow up (average of 214 days), there were no limb losses, graft infections or vascular complications in either the endovascular or open surgical group. CONCLUSIONS: Endovascular treatment is a viable option for axillo-subclavian vessel injuries. Preliminary results demonstrate that endovascular treatment, when compared to open surgical repair, can have similar rates of technical success and long-term outcomes in patency, infection and vascular complications.

Conservative Management of Non-Infected Diabetic Foot Ulcers Achieves Reliable Wound Healing and Limb Salvage in the Setting of Mild-Moderate Ischemia.

BACKGROUND: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing among patients with critical limb threatening ischemia (CLTI). Our goal was to analyze the use of a previously reported conservative wound care approach to non-infected (foot infection score of zero), diabetic foot ulcers with mild-moderate peripheral arterial disease enrolled in a conservative tier of a multidisciplinary limb preservation program. METHODS: Veterans with CLTI and tissue loss were prospectively enrolled into our Prevention of Amputation in Veterans Everywhere (PAVE) program. All patients with wounds were stratified to a conservative approach based on perfusion evaluation and a validated pathway of care. Retrospective analysis of a prospectively maintained database was performed to evaluate all conservatively managed patients presenting without foot infection for the primary outcome of wound healing as well as secondary outcomes of time to wound healing, delayed revascularization, wound recurrence, and limb loss. RESULTS: Between January 2006 and December 2019, 1113 patients were prospectively enrolled into the PAVE program. A total of 241 limbs with 281 wounds (217 patients) were stratified to the conservative approach. Of these, 122 limbs (89 patients) met criteria of having diabetic foot wounds without infection at the time of enrollment and are analyzed in this report. Of the 122 limbs, 97 (79.5%) healed their index wound with a mean time to healing of 4.6 months (0.5-20 months). Wound recurrence ensued in 44 (45.4%) limbs, 93.2% of which healed again after recurrence. There were three (3.1%) limbs requiring major amputation in this group (one due to uncontrolled infection and two due to ischemic tissue loss). Of the 25 (20.5%) limbs that did not heal initially, four (16%) required amputation due to progressive symptoms of CLTI. CONCLUSIONS: In patients with diabetes and lower extremity wounds without infection in the setting of mild to moderate peripheral arterial disease, there appears to be an acceptable rate of index wound healing, and appropriate rate of recurrent wound healing with a low risk of limb loss. While wound recurrence is frequent, this can be successfully treated without the need for revascularization.

A single center's 15-year experience with palliative limb care for chronic limb threatening ischemia in frail patients.

OBJECTIVE: Our institution's multidisciplinary Prevention of Amputation in Veterans Everywhere (PAVE) program allocates veterans with critical limb threatening ischemia (CLTI) to immediate revascularization, conservative care, primary amputation, or palliative limb care according to previously reported criteria. These four groups align with the approaches outlined by the global guidelines for the management of CLTI. In the present study, we have delineated the natural history of the palliative limb care group of patients and quantified the procedural risks and outcomes. METHODS: Veterans prospectively enrolled into the palliative limb cohort of our PAVE program from January 2005 to January 2020 were analyzed. The primary outcome was mortality. The secondary outcomes included overall and limb-related readmissions, limb loss, and wound healing. The clinical frailty scale (CFS) score was calculated, and the 5-year expected mortality was estimated using the Veterans Affairs Quality Enhancement Research Initiative tool. Regression analysis was performed to establish associations among the following variables: mortality, wound, ischemia, and foot infection (WIfI) score, CFS score, overall admissions, and limb-related admissions. RESULTS: The PAVE program enrolled 1158 limbs during 15 years. Of the 1158 limbs, 157 (13.5%) in 145 patients were allocated to the palliative limb care group. The overall mortality of the group was 88.2% (median interval, 3.5 months; range, 0-91 months). Of the 128 patients who had died, 64 (50%) had died within 3 months of enrollment. The predicted 5-year mortality for the group was 66%. The average CFS score for the group was 6.2, denoting persons moderately to severely frail. Using the CFS score, 106 patients were considered frail and 39 were considered not frail. No differences were found in mortality between the frail and nonfrail patients. However, a statistically significant difference was found in early (<3 months) mortality (56.2% vs 37.5%; P = .032). The 30-day limb-related readmission rate was 4.7%. Eventual major amputation was necessary for 18 limbs (11.5%). Wound healing occurred in 30 patients (20.6%). Regression analysis demonstrated no association between the CFS score and mortality (r = 0.55; P = .159) or between the WIfI score and mortality (r = 0.0165; P = .98). However, a significant association was found between the WIfI score and limb-related admissions (r = 0.97; P < .001). CONCLUSIONS: Frail patients with CLTI had high early mortality and a low risk of limb-related complications. They also had a low incidence of deferred primary amputation or limb-related readmissions. In our cohort, the vast majority of patients had died within a few months of enrollment without requiring an amputation. A comprehensive approach to the treatment of CLTI patients should include a palliative limb care option because a significant proportion of these patients will have limited survival and can potentially avoid unnecessary surgery and major amputation.

Factors Affecting One-Year Outcomes After Major Lower Extremity Amputation in the Vascular Quality Initiative Amputation Registry.

INTRODUCTION: Major lower extremity amputation (LEA) results in significant morbidity and mortality. This study identifies factors contributing to adverse long-term outcomes after major LEA. STUDY DESIGN: Amputations in the Vascular Quality Initiative (VQI) long-term follow-up database from 2012 to 2017 were included. Multivariable logistic regression determined which significant patient factors were associated with 1-year mortality, long-term functional status, and progression to higher level amputation within 1 year. RESULTS: 3440 major LEAs were performed and a mortality rate of 19.9% was seen at 1 year. Logistic regression demonstrated that 1-year mortality was associated with post-op myocardial infarction (MI) (odds ratio (OR) 1.7, CI 1.02-2.97, P = .04), congestive heart failure (CHF) (OR 1.9, confidence interval (CI) 1.56-2.38, P < .001), hypertension (HTN) (OR 1.31, CI 1.00-1.72, P = .05), chronic obstructive pulmonary disease (COPD) (OR 1.36, CI 1.13-1.63, P < .001), and dependent functional status (OR 2.01, CI 1.67-2.41, P < .001). A decline in ambulatory status was associated with COPD (OR 1.36, CI 1.09-1.68, P = .006). Dependent functional status was protective against revision to higher level amputation (OR .18, CI .07-.45, P < .001). CONCLUSION: In the VQI, 1-year mortality after major LEA is nearly 20% and associated with HTN, CHF, COPD, dependent functional status, and post-op MI. Decreased functional status at 1 year was associated with COPD, and progression to higher level amputation was less likely in patients with dependent functional status.

Lumbar and sacral brucellosis due to queso fresco ingestion.

Brucellosis is rare in the USA, with 100-200 cases reported annually. In this case we illustrate the complex management of spinal brucellosis. A 22-year-old male presented with 3 months of low back pain. Imaging revealed osteomyelitis/diskitis of L5/S1 and abscesses involving the pre-vertebral, epidural and pelvic recesses. Initial biopsies were inconclusive, but the patient later endorsed eating unpasteurized cheese (queso fresco) from Mexico; therefore, Brucella serology was sent and was positive. Despite aggressive antibiotic therapy there was disease progression. The patient underwent debridement of the involved vertebrae and drainage. Multiple cultures failed to grow the organisms, but Brucella polymerase chain reaction was positive. A month later he underwent a second vertebral debridement as well as placement of tobramycin impregnated beads in the vertebral space. He has since recovered. Surgery should be considered if there is a poor response to medical management and patients may need repeated debridement.

Health Care System-Wide Analysis Identifies High Radiation Use Factors and Behaviors in Surgery.

OBJECTIVE: Usage of radiation among various surgical specialists has not been comprehensively evaluated. A systems-based analysis evaluating intraoperative radiation can help identify high use factors and dose reduction behaviors leading to quality improvement initiatives. METHODS: A retrospective review of all operative fluoroscopic-guided procedures from 2010 to 2017 from 4 hospitals in a tertiary academic health care system was performed. RESULTS: One thousand two hundred fifty-two cases were analyzed, and notable trends in metrics including type of equipment, procedures, surgical field, surgical specialty, and dose reduction techniques were demonstrated. Higher radiation exposures were correlated with fixed vs. mobile C-arm usage (1229 mGy vs. 331 mGy, P = .001), abdominal/pelvic procedures (429.2 mGy vs. 274.0 mGy, P = .002), and embolization (2450.6 mGy vs. 328.2 mGy, P = .019). Vascular surgery averaged 40 times higher radiation exposure per patient than other specialties (613.3 mGy vs. 15.6 mGy, P = .001). Notably, vascular surgeons utilized dose reduction techniques less frequently than urology (21.5% vs. 70%, P = .001) but more than neurosurgery and orthopedics (21.5% vs. 1.3% and 0%, P = .001, respectively). CONCLUSIONS: A system-wide health care analysis identified vascular surgery procedures, use of a fixed C-arm, abdominal/pelvic procedures, and embolization cases as having the highest radiation exposure. These data can serve as baseline information for future quality improvement initiatives regarding fluoroscopy usage by surgeons.

5-Item Modified Frailty Index Predicts Outcomes After Below-Knee Amputation in the Vascular Quality Initiative Amputation Registry.

Patient frailty indices are increasingly being utilized to anticipate post-operative complications. This study explores whether a 5-factor modified frailty index (mFI-5) is associated with outcomes following below-knee amputation (BKA). All BKAs in the vascular quality initiative (VQI) amputation registry from 2012-2017 were reviewed. Preoperative frailty status was determined with the mFI-5 which assigns one point each for history of diabetes, chronic obstructive pulmonary disease or active pneumonia, congestive heart failure, hypertension, and nonindependent functional status. Outcomes included 30-day mortality, unplanned return to odds ratio (OR), post-op myocardial infarction (MI), post-op SSI, all-cause complication, revision to higher level amputation, disposition status, and prosthetic use. 2040 BKAs were performed. Logistic regression showed an increasing mFI-5 score that was associated with higher risk of combined complications (OR 1.22, confidence interval [CI] 1.07-1.38, P < .05), 30-day mortality (OR 1.60, CI 1.19-2.16, P < .05), post-op MI (OR 1.79, CI 1.30-2.45, P < .05), and failure of long-term prosthetic use (OR 1.17, CI 1.03-1.32, P < .05). In the VQI, every one-point increase in mFI-5 is associated with an increased risk of 22% for combined complications, 60% for 30-day mortality, nearly 80% for post-op MI, and 17% for failure of prosthetic use in BKA patients. The mFI-5 frailty index should be incorporated into preoperative planning and risk stratification.

A conservative approach to select patients with ischemic wounds is safe and effective in the setting of deferred revascularization.

OBJECTIVE: The Wound, Ischemia, and foot Infection classification system has been validated to predict benefit from inmediate revascularization and major amputation risk among patients with peripheral arterial disease. Our primary goal was to evaluate wound healing, limb salvage, and survival among patients with ischemic wounds undergoing revascularization when intervention was deferred by a trial of conservative wound therapy. METHODS: All patients with peripheral arterial disease and tissue loss are prospectively enrolled into our Prevention of Amputation in Veterans Everywhere limb preservation program. Limbs are stratified into a validated pathway of care based on predetermined criteria (immediate revascularization, conservative treatment, primary amputation, and palliative care). Limbs allocated to the conservative strategy that failed to demonstrate adequate wound healing and were candidates, underwent deferred revascularization. Rates of wound healing, freedom from major amputation, and survival were compared between patients who underwent deferred revascularization with those who received immediate revascularization by univariate and multivariate analysis. RESULTS: Between January 2008 and December 2017, 855 limbs were prospectively enrolled into the Prevention of Amputation in Veterans Everywhere program. A total of 203 limbs underwent immediate revascularization. Of 236 limbs stratified to a conservative approach, 185 (78.4%) healed and 33 (14.0%) underwent deferred revascularization (mean, 2.7 ± 2.6 months). The mean long-term follow-up was 51.7 ± 37.0 months. Deferred compared with immediate revascularization demonstrated similar rates of wound healing (66.7% vs 57.6%; P = .33), freedom from major amputation (81.8% vs 74.9%; P = .39), and survival (54.5% vs 50.7%; P = .69). After adjustment for overall Wound, Ischemia, and foot Infection stratification stages, deferred revascularization remained similar to immediate revascularization for wound healing (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.7-3.2), freedom from major amputation (HR, 0.7; 95% CI, 0.3-1.7) and survival (HR, 1.2; 95% CI, 0.6-2.4). CONCLUSIONS: Limbs with mild to moderate ischemia that fail a trial of conservative wound therapy and undergo deferred revascularization achieve similar rates of wound healing, limb salvage, and survival compared with limbs undergoing immediate revascularization. A stratified approach to critical limb ischemia is safe and can avoid unnecessary procedures in selected patients.

Native Microchannel Recanalization with Orbital Atherectomy as a Viable Alternative to Failed Standard Recanalization of TASC II D Aortoiliac Occlusive Disease.

BACKGROUND: Endovascular treatment of Trans-Atlantic Inter-Society Consensus (TASC) II D aortoiliac lesions is now an accepted form of revascularization. We sought to demonstrate that native microchannel recanalization and orbital atherectomy is a successful recanalization method of TASC II D aortoiliac lesions refractory to standard recanalization techniques. METHODS: Four consecutive patients from 2016 to 2018 with symptomatic TASC II D aortoiliac occlusive disease prohibitive for open bypass and failed traditional prodding guidewire or device recanalization technique were identified and underwent advanced native microchannel selection and subsequent orbital atherectomy (Cardiovascular Systems, Inc, St Paul, MN). Native microchannels of the calcified lesions were probed and traversed with a 0.014″ wire. The atherectomy crown was tracked over the wire, and orbital atherectomy was initiated with a 1.25 mm crown starting at the lowest revolution and continued until the microchannel is sufficiently large to track a 1.2 mm-balloon for angioplasty. Serial microchannel angioplasty with exchange for stiffer and/or larger profile wires and balloons was achieved until a covered stent could be safely deployed across the target lesion. The kissing stent technique was then used to recreate the aortic bifurcation. A ViperSlide lubricant solution was used in all cases per indication for use. Patients were all heparinized to maintain an activated clotting time of 250. Lesion characteristics, survival, limb salvage, patency, and change in clinical symptoms were also analyzed. RESULTS: All 4 patients underwent successful native microchannel recanalization and orbital atherectomy of the common iliac artery (CIA). There were no intraoperative ruptures, embolizations, or dissections. All 4 patients presented with unilateral CIA occlusion with contralateral CIA stenosis. The average occlusion lesion length of the CIA was 6.0 cm. The average contralateral stenosis length was 2.3 cm. The kissing stent technique was used in all patients for reconstruction of the aortic bifurcation. At 30 days, all patients had improvement in pain and primary patency of 100%. Long-term follow-up at 21.6 months noted continued improvement in symptoms and primary patency of 75%. The fourth patient died at 4 months from lung cancer with occluded iliac stents by imaging at that time. CONCLUSIONS: Native microchannel recanalization with subsequent orbital atherectomy is an option in high-risk patients with TASC II D aortoiliac disease who have failed traditional recanalization techniques. Further work in proper patient selection and safe utilization of atherectomy devices in the CIA is needed.

Immediate Carotid Endarterectomy Is Associated with Higher Risk in Symptomatic Patients.

BACKGROUND: Guidelines recommend that patients with carotid artery stenosis ≥50% (Sx-CAS) undergo carotid endarterectomy (CEA) within 14 days of symptoms. However, perioperative risks, especially stroke, may be increased when CEA is performed within 48 hours. This study seeks to more fully evaluate the effect of timing of surgery on outcomes for Sx-CAS. METHODS: All CEAs in the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) from 2012 to 18 were reviewed. Ipsilateral cortical or visual symptoms within 6 months defined Sx-CAS. Timing from symptom occurrence to CEA was classified as immediate (0-2 days), early (3-14 days), or delayed (>14 days). Perioperative stroke, myocardial infarction (MI), and 30-day mortality rates were compared by time to surgery. RESULTS: Of 2203 CEAs, 436 (20%) were for Sx-CAS (52% stroke, 48% transient ischemic attack). Mean time from symptoms to CEA was 28.3 days (range, 0-172; median, 14 days). Sixty-one cases (14%) were immediate, 166 (38%) early, and 209 (48%) delayed. Perioperative stroke occurred in 2.8% and stroke/MI/30-day mortality in 5.7%. Stroke rate was significantly higher in the immediate group (vs. early and delayed): 8.2%, versus 3.0%, and 0.96%, respectively (P = 0.009). Stroke/MI/30-day mortality was also higher in the immediate group: 13.1%, versus 6.0%, and 3.3%, respectively (P = 0.001). Immediate surgery was associated with greater postoperative events (P = 0.009), and logistic regression confirmed decreased risk of postoperative stroke and stroke/MI/30-day mortality in delayed surgery using immediate surgery as a reference. Wide variability existed among centers in the timing of CEA (immediate-range, 0-50%; delayed-range, 41-83%; P = 0.01). CONCLUSIONS: In the SoCal VOICe, 52% of patients undergo CEA within 2 weeks of symptoms. Increased stroke rates occur when CEA is performed within 2 days, whereas stroke and death rates are decreased at 3-14 days and beyond. These data support avoidance of immediate CEA. Opportunity exists to standardize timing of CEA for Sx-CAS among SoCal VOICe participants. Further study is required to define the role of immediate CEA.

Multidisciplinary approach achieves limb salvage without revascularization in patients with mild to moderate ischemia and tissue loss.

OBJECTIVE: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing and limb salvage of patients with peripheral artery disease (PAD). Our goal was to evaluate the association between WIfI stage and wound healing, limb salvage, and survival in a select cohort of patients with PAD and tissue loss undergoing an attempt of wound healing without immediate revascularization (conservative approach) in a multidisciplinary wound program. METHODS: Veterans with PAD and tissue loss were prospectively enrolled in our Prevention of Amputation in Veterans Everywhere (PAVE) program. Limbs were stratified to a conservative, revascularization, primary amputation, and palliative limb care approach based on the patient's fitness, ambulatory status, perfusion evaluation, and validated pathway of care. Rates of wound healing, wound recurrence, limb salvage, and survival were retrospectively analyzed by WIfI clinical stages (stage 1-4) in the conservative group. Cox regression modeling was used to estimate clinical outcomes by WIfI stage. RESULTS: Between January 2006 and October 2017, there were 961 limbs prospectively enrolled in our PAVE program. A total of 233 limbs with 277 wounds were stratified to the conservative approach. WIfI staging distribution included 19.7% stage 1, 20.2% stage 2, 38.6% stage 3, and 21.5% stage 4. All ischemia scores were classified as 1 or 2. Advanced wound interventions and minor amputations were performed on 40 limbs (16.6%) and 57 limbs (23.7%), respectively. Average long-term follow-up was 41.4 ± 29.0 months. Complete wound healing without revascularization was achieved in 179 limbs (76.8%) during 4.4 ± 4.1 months. Thirty-four limbs (14%) underwent deferred revascularization because of a lack of complete wound healing. At long-term follow-up, wound recurrence per limb was 39%. Overall limb salvage at long-term follow-up was 89.3%. Stratified by WIfI stage, there was no statistically significant difference between groups for wound healing (P = .64), wound recurrence (P = .55), or limb salvage (P = .66) after adjustment for significant patient, limb, and wound characteristics. CONCLUSIONS: In select patients with mild to moderate ischemia and tissue loss, a stratified approach can achieve acceptable rates of wound healing and limb salvage, with limited need for deferred revascularization. WIfI clinical staging did not predict wound healing, limb salvage, or survival in this cohort.

Analysis of Subjective and Objective Screening Techniques as Predictors of Safety for Radial Artery Intervention.

BACKGROUND: There is no currently accepted standard in safety evaluation for radial artery intervention. We sought to compare the accuracy of various subjective and objective screening techniques in predicting safety for radial artery intervention. METHODS: Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test, objective Barbeau test, and several objective hand ultrasound techniques to assess safety for radial artery intervention. These results were then compared to the gold standard of conventional hand angiography to document complete palmar arch. Statistical analysis including sensitivity, specificity, positive predictive values, negative predictive values, and accuracy were calculated. RESULTS: Compared to hand angiography, the subjective Allen's test and the objective Princeps Pollicis Artery ultrasound demonstrated the comparable levels of sensitivity (100% vs. 96.7%, respectively), specificity (100% vs. 100%, respectively), and accuracy (97.2% vs. 97.1%, respectively). The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%). CONCLUSIONS: There is no currently accepted standard in safety evaluation for radial artery intervention. However, preliminary data suggest that certain subjective and objective techniques such as Allen's testing, Princeps Pollicis artery ultrasound, and Barbeau testing are comparable options in predicting palmar arch patency.